主要ポイント
- Lot identity must be unbroken from producing plant to your production batch.
- Traceability is tested by exercise, not by description.
- One-up/one-down is the minimum; full-chain visibility is the objective.
The unbroken lot chain
Producer lot number must appear on the certificate, the packing list and the packaging, and must be captured in your goods receipt and linked to your production batch. A break at any point makes a recall or investigation partly guesswork.
Testing traceability with an exercise
Select a finished feed batch and trace every ingredient lot back to supplier certificates within a defined time limit, then forward from one ingredient lot to all affected batches. Time and completeness of the result are the measure.
Where traceability usually breaks
Bulk silo commingling, repackaging by intermediaries, transfer between storage locations without record, and manual re-entry of lot numbers. Each of these needs a defined control rather than an assumption.
実施手順
- Require producer lot identification on certificates, packing lists and packaging.
- Record the supplier lot at goods receipt and link it to storage location.
- Link ingredient lots to each production batch.
- Run a documented traceability exercise on a defined cadence.
- Record exercise time and gaps, and close the gaps.
確認事項
- Producer lot number present and consistent across all documents
- Goods receipt capturing supplier lot and storage location
- Documented traceability exercise results with time to completion
管理すべきリスク
- Commingled bulk storage destroying lot identity
- Repackaging removing original lot marking
- Traceability described in the quality manual but never exercised
よくある誤り
- Accepting deliveries without recording the supplier lot
- Assuming a certification covers traceability performance
- Running traceability exercises only before an external audit
用語
- One-up/one-down
- Ability to identify the immediate supplier of a material and the immediate recipient of the product made from it.
よくある質問
How fast should a traceability exercise complete?
Fast enough to support a withdrawal decision. Many operations target a few hours; the important step is to measure your actual time and improve it deliberately.
Does bulk handling make traceability impossible?
No, but it requires silo management rules: recording which lots entered which silo, and defining how commingled stock is identified going forward.